Jun. 20 at 12:36 PM
$DERM Journey Medical announces data analysis from Phase 3 trials of Emrosi
Journey Medical announced that a data analysis from two Phase 3 multicenter clinical trials, evaluating Emrosi for the treatment of moderate-to-severe papulopustular rosacea in adults will be presented at the Society of Dermatology Physician Associates 2025 Summer Dermatology Conference taking place June 25-29 in Washington, DC. The analysis determined that differences in body weight did not affect the efficacy of Emrosi in the two Phase 3 trials, which supported its November 2024 FDA approval.
Subjects in the double-blind, placebo-controlled Minocycline Versus Oracea in Rosacea-1 and Minocycline Versus Oracea in Rosacea-2 Phase 3 clinical trials were randomized in a 3:3:2 ratio to treatment with Emrosi, doxycycline 40 mg, or placebo once daily for 16 weeks. The coprimary efficacy endpoints were: the proportion of participants demonstrating Investigator's Global Assessment treatment success with Emrosi vs. placebo; and reductions in total inflammatory lesion counts with Emrosi vs. placebo.
Comparisons between Emrosi and doxycycline were secondary endpoints. Sub-group analyses were conducted in patients with body weight less than or equal to the median body weight and in patients with body weight greater than the median body weight. Of the 653 participants enrolled, 323 were randomized in MVOR-1 and 330 were randomized in MVOR-2. The median body weight at baseline was 83.5 kg in MVOR-1 and 83.0 kg in MVOR-2.
Emrosi showed superior efficacy on both co-primary endpoints, in both the body weight categories, compared to placebo and doxycycline. Emrosi was generally well tolerated, with no notable between-group differences in the frequency or severity of reported adverse events.
